A Single Dose Escalation Study of PCSK9 Inhibitor (JS002) in Health Subjects

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2017
JS002 is a recombinant humanized Anti- PCSK9 monoclonal antibody; This is a phase Ia, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single subcutaneous injection of JS002 in healthy subjects. In this study, the dose ascending design includes five dose level cohorts (15 mg, 50 mg, 150 mg, 300 mg, and 450 mg) administered by subcutaneous injection, and three intravenous administration cohorts (15 mg, 150 mg, and 450 mg). Each cohort will enroll 8 to 12 subjects (distribution of study drug and placebo in a 3:1 ratio). The duration of the study is 84-day per subjects.
Epistemonikos ID: d4597db080671b2cb7bcffdc4cda1ab09bdaa31e
First added on: May 06, 2024